Flu Vaccine Shows Promise in Phase III Trials
Studies test subcutaneous and intramuscular administration (January 15)
Summary results have been reported from two phase III clinical trials of the recombinant seasonal influenza HA vaccine ASP7374 (Astellas Pharma/UMN Pharma), which completed vaccine administration in October 2013.
One of these studies enrolled 900 healthy volunteers aged 20 to 64 years to compare the immunogenicity and safety of subcutaneously administered ASP7374 with that of approved egg-derived trivalent inactivated vaccine and to demonstrate the noninferiority of ASP7374 to the egg-derived vaccine.
This study showed noninferiority of the recombinant seasonal influenza HA vaccine ASP7374 in comparison with the egg-based vaccine in terms of immunogenicity. No major safety problem was observed.
The second phase III trial enrolled 55 healthy volunteers aged 61 years and older to evaluate the immunogenicity and safety of intramuscularly administered ASP7374. This trial also showed favorable immunogenicity.
The ASP7374 vaccine contains three different strains of antigens and is produced by a cell-culture manufacturing method.
Source: UMN Pharma Inc.; January 15, 2014.